Regulatory Affairs Officer II - Office based - Reading UK

PURPOSE
Prepares and/or reviews regulatory submissions to support clinical trial and marketing authorization activities for either internal and/or external clients. Provides regulatory support for assigned projects.

RESPONSIBILITIES
• Acts as a Regulatory Team member involved in projects, under the guidance of senior staff.
• Manages day-to-day workload in collaboration with senior staff, as appropriate.
• Prepares and/or reviews regulatory documentation in area of expertise, as appropriate.
• Actively participates with internal and external customers and communicates confidently in straightforward matters.
• Understands the Scope of Work, and deliverables for a given project.
• May prepare slides and background material for meetings under senior guidance and present to clients by phone or in person.
• Preparation of submissions including Marketing Authorization Transfer, CMC variation filling, initial MAA filling, labelling updates, CMC authoring and \ or updates as required.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Technical Skills/Experience
• 4-5 years regulatory experience, focusing on lifecycle maintenance of marketed products in Europe and/or emerging markets (e.g. variations, renewals, new Marketing Authorization Applications (MAAs) submissions)
• Preparation of relevant CTD (Common Technical Dossier) documents to support submissions (mainly Module 1), in collaboration with Technical/CMC/Labelling experts
• Quality review of technical/ regulatory documents
• Interaction with Regulatory Agencies (EU and/or National Agency)
• Regulatory strategy and determination of documentation requirements, timelines, budgets
• Revision/review of regulatory SOPs, as appropriate
• Project management experience - an advantage
• Broad experience in preparing international dossiers including APAC regulatory requirements.
Soft Skills
• Ability to work to tight timelines and manage peaks in workload
• Good team player
• Good negotiating skills and the ability to identify and resolve issues
• Excellent verbal and written communication skills
• Excellent computer skills e.g. Word, Excel, data and document management systems
• Cultural awareness for global ways of working
• Able to act as a mentor to junior colleagues and to assist in their training and development as appropriate

MINIMUM REQUIRED EDUCATION AND EXPERIENCE
• Degree in life science-related discipline or professional equivalent plus at least 5 year’s relevant experience*
(*or combination of education, training and experience)
• 5 years regulatory experience, focusing on lifecycle maintenance of marketed products in Europe and/or emerging markets (e.g. variations, renewals, new Marketing Authorisation Applications (MAAs) submissions